oSIST prEN ISO 10993-7:2024
(Main)Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO/DIS 10993-7:2024)
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO/DIS 10993-7:2024)
ISO 10993-7:2008 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining compliance so that devices may be released. Additional background, including guidance and a flowchart showing how the standard is applied are also included in informative annexes.
EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by ISO 10993-7:2008.
Biologische Beurteilung von Medizinprodukten - Teil 7: Ethylenoxid-Sterilisationsrückstände (ISO/DIS 10993-7:2024)
Dieses Dokument legt die zulässigen Grenzwerte für den Restgehalt von Ethylenoxid (EO) und Ethylenchlorhydrin (ECH) in mit EO sterilisierten Medizinprodukten, die Verfahren für die Messung von EO und ECH sowie die Verfahren für die Bestimmung der Übereinstimmung fest, damit die Produkte freigegeben werden dürfen. Weitere Hintergrundinformationen, eine Anleitung und ein Flussdiagramm, auf dem dargestellt ist, wie dieses Dokument angewendet wird, sind ebenfalls in den informativen Anhängen enthalten.
EO sterilisierte Produkte oder Komponenten, die weder direkten noch indirekten Patientenkontakt haben (z. B. In vitro-Diagnostika), liegen außerhalb des Anwendungsbereiches dieses Dokuments. Dieses Dokument gilt nicht für Produkte, für die nachgewiesen wurde, dass sie EO oder dessen Abbauprodukt ECH nicht absorbieren oder zurückhalten, beispielsweise Medizinprodukte, die ausschließlich aus Metalllegierungen und Glas hergestellt wurden, siehe C.5 [228].
ANMERKUNG Dieses Dokument spezifiziert keine Grenzwerte für Ethylenglykol (EG). Für EG wurden keine produktbezogenen Grenzwerte festgelegt, da die Risikoabschätzung in Anhang F ergeben hat, dass die berechneten zulässigen Gehalte höher sind als die voraussichtlich bei einem Medizinprodukt auftretenden Gehalte.
Évaluation biologique des dispositifs médicaux - Partie 7: Résidus de stérilisation à l'oxyde d'éthylène (ISO/DIS 10993-7:2024)
L'ISO 10993-7:2007 spécifie les limites admissibles des résidus d'oxyde d'éthylène (OE) et de chlorhydrate d'éthylène (ECH) pour des dispositifs médicaux individuels stérilisés à l'oxyde d'éthylène, les modes opératoires pour le mesurage de l'oxyde d'éthylène et du chlorhydrate d'éthylène et les méthodes de mesure en vue de déterminer leur conformité et de procéder à leur libération. Une documentation supplémentaire, y compris des directives et un diagramme de flux sont également inclus dans les annexes informatives.
Biološko ovrednotenje medicinskih pripomočkov - 7. del: Ostanki po sterilizaciji z etilenoksidom (ISO/DIS 10993-7:2024)
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Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2024
Biološko ovrednotenje medicinskih pripomočkov - 7. del: Ostanki po sterilizaciji z
etilenoksidom (ISO/DIS 10993-7:2024)
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
(ISO/DIS 10993-7:2024)
Biologische Beurteilung von Medizinprodukten - Teil 7: Ethylenoxid-
Sterilisationsrückstände (ISO/DIS 10993-7:2024)
Évaluation biologique des dispositifs médicaux - Partie 7: Résidus de stérilisation à
l'oxyde d'éthylène (ISO/DIS 10993-7:2024)
Ta slovenski standard je istoveten z: prEN ISO 10993-7
ICS:
11.100.20 Biološko ovrednotenje Biological evaluation of
medicinskih pripomočkov medical devices
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT
International
Standard
ISO/DIS 10993-7
ISO/TC 194
Biological evaluation of medical
Secretariat: DIN
devices —
Voting begins on:
Part 7: 2024-06-17
Ethylene oxide sterilization
Voting terminates on:
2024-09-09
residuals
Évaluation biologique des dispositifs médicaux —
Partie 7: Résidus de stérilisation à l'oxyde d'éthylène
ICS: 11.100.20
THIS DOCUMENT IS A DRAFT CIRCULATED
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Reference number
ISO/DIS 10993-7:2024(en)
DRAFT
ISO/DIS 10993-7:2024(en)
International
Standard
ISO/DIS 10993-7
ISO/TC 194
Biological evaluation of medical
Secretariat: DIN
devices —
Voting begins on:
Part 7:
Ethylene oxide sterilization
Voting terminates on:
residuals
Évaluation biologique des dispositifs médicaux —
Partie 7: Résidus de stérilisation à l'oxyde d'éthylène
ICS: 11.100.20
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2024
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
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Published in Switzerland Reference number
ISO/DIS 10993-7:2024(en)
ii
ISO/DIS 10993-7:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 5
4.1 General .5
4.2 Categorization of devices .6
4.3 Allowable limits .6
4.3.1 General .6
4.3.2 Limited contact devices .7
4.3.3 Prolonged contact devices .8
4.3.4 Long-term contact devices .8
4.3.5 Special situations .9
4.3.6 Tolerable contact level .10
4.4 Determination of EO and ECH residuals .11
4.4.1 Procedure .11
4.4.2 Test method validation .11
4.4.3 Product sampling .11
4.4.4 Product extraction .11
4.4.5 Multi-device Systems . 12
5 Product release .12
5.1 General . 12
5.2 Batch release of products . . 12
5.3 Release of products at defined minimum aeration time . 12
5.4 Procedure for product release using residual dissipation curves . 13
6 Adoption of products into established aeration family . 14
7 Requalification. 14
Annex A (informative) Guidance for the application of this document for the determination of
EO and ECH residuals in medical devices .15
Annex B (informative) Factors influencing product residuals .25
Annex C (informative) Rationale for the provisions of this document .28
Annex D (informative) Establishment of allowable limits for EO .33
Annex E (informative) Establishment of allowable limits for ECH .50
Annex F (informative) Ethylene Glycol .60
Annex G (normative) Evaluation of gas chromatograms .64
Annex H (informative) Gas chromatographic determination for EO and ECH .68
Annex I (informative) Preparation of EO and ECH standards .72
Annex J (informative) Ethylene oxide and ethylene chlorohydrin residual measuring methods . 76
Annex K (informative) Examples of product release methods .84
Annex ZA (informative) Relationship between this European Standard the General Safety and
Performance Requirements of Regulation (EU) 2017/745 aimed to be covered .102
Bibliography .105
iii
ISO/DIS 10993-7:2024(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent
rights identified during the development of the document will be in the Introduction and/or on the ISO list of
patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 194, Biological and clinical evaluation of
medical devices.
This third edition cancels and replaces the second edition (ISO 10993-7:2008, ISO 10993-7:2008/Cor 1:2009
and ISO 10993-7:2008/Amd 1:2019), which has been technically revised. This edition shall be implemented
within 3 years of publication.
The main changes compared to the previous edition are as follows:
— manufacturer to define allowable limits and extraction conditions, based on the patient population and
the duration of use;
— allow for the use of a risk assessment to establish allowable limits;
— provide additional guidance
...
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